Global Regulatory Lead, Senior Director

Global Regulatory Lead, Senior Director role at Dompé is to play a critical role in developing and executing global regulatory strategies to support product development, registration, and compliance. Reporting to the Vice President of Regulatory Affairs, this position will serve as a key liaison with regulatory health authorities, oversee regulatory submissions, and provide strategic guidance to cross-functional teams. The ideal candidate will have extensive experience in regulatory affairs within the pharmaceutical or biotech industry, a strong understanding of U.S. and international regulations, and the ability to navigate complex regulatory environments to drive successful outcomes.

• Develop and Execute Regulatory Strategies – Provide regulatory expertise across early and late-stage clinical development, ensuring compliance with U.S. and international requirements.
• Lead Regulatory Submissions and Compliance – Oversee the preparation, submission, and management of investigational and registration applications (eCTD) while coordinating with Regulatory Operations for e-submissions.
• Risk Assessment and Cross-Functional Collaboration – Identify and escalate regulatory risks, ensuring seamless collaboration across teams to drive successful regulatory outcomes.

• Deep understanding of global regulatory frameworks (FDA, EMA, ...)
• Expertise in IND, CTAs, NDAs, BLAs and regulatory pathways (Orphan Drug Designation,...)
• Ability to develop and translate regulatory strategies into actionable global development plans.
• Ability to manage multiple priorities, assess risks, and navigate complex regulatory environments with precision and flexibility.

Joining Dompé as a Global Regulatory Lead, Senior Director offers a unique opportunity to be part of a rapidly growing global biopharmaceutical company with a rich history of innovation. This role provides the chance to lead regulatory strategies for groundbreaking therapies, collaborate with cross-functional teams, and engage directly with health authorities to drive successful product approvals. With a dynamic and entrepreneurial culture, Dompé fosters professional growth, values strategic thinking, and empowers its employees to make a meaningful impact on global healthcare.

If you thrive in a fast-paced, high-impact environment and are passionate about advancing innovative treatments, this is the perfect opportunity for you.

• Support Global Product Teams by contributing to and implementing regulatory strategies to optimize global product development and registration activities.
• Manage regulatory communications/interactions with regulatory health authorities and ensure compliance with applicable regional regulations for assigned development projects in the US and ex-US countries.
• Represent the Regulatory Affairs department on multidisciplinary product development teams.
• Serve as primary point-of-contact for communication with regulatory health authorities on assigned programs.
• Lead team preparations for milestone development/registration meetings with regulatory health authorities.
• Contribute content and collaborate cross-functionally for preparation of CTA/IND/NDA/BLAs, amendments/variations, safety, and annual reports.
• Coordinate with external vendors to maintain registration and lifecycle of assigned products globally.
• Support investigational studies, i.e., protocol review, IND/CTA regulatory documents preparation, review, submission and maintenance, CSR review.
• Prepare strategy for orphan drug designations, pediatric study plan and acceleration pathway applications if applicable for the assigned projects.
• Proactively prioritize and complete multiple projects within established deadlines.
• Maintain awareness of evolving FDA and international regulations and interpretation, competitive landscape, regulatory precedents, and work cross-functionally to implement those evolved regulations for the assigned projects.

• Doctorate degree and 10+ years in the pharmaceutical, biotech, or related industries and 8+ years of regulatory affairs.
• Master 27s degree and 12+ years in the…